PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

Hazard

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Details from the source

Reason for recall: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Quantity: 670 units (106 US, 564 OUS) Lot/code info: (1) System Code: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278, 46, 277, 115, 150, 163, 131, 71, 104, 132, 147, 208, 244, 75, 36, 234, 141, 70, 26, 148, 133, 57, 128, 188, 151, 68, 233, 111, 255, 43, 33, 22, 146, 256, 270, 238, 187, 74, 154, 157, 251, 237, 222, 95, 53, 262, 29, 59, 209, 260, 191, 274, 52, 107, 218, 169, 231, 142, 143, 144, 275, 127, 210, 211, 212, 213, 206, 30, 23, 265, 190, 268, 203, 138, 34, 113, 254, 140, 266, 60, 97, 45, 112, 134, 100, 101, 168, 235, 272, 58, 47, 273, 176, 64, 156, 276, 232, 54, 55, 165, 25, 271, 35, 202, 149, 243, 32, 224, 207, 76, 108, 226, 48, 264, 102, 84, 105, 99, 21, 159, 49, 185, 51, 239, 40, 94, 63, 96, 129, 245, 186, 130, 252, 161, 120, 170, 195, 196, 197, 171, 200, 193, 80, 28, 229, 145, 79, 93, 137, 50, 44, 38, 175, 227, 167, 78, 86, 91, 189, 198, 37, 72, 199, 88, 27, 121, 179, 183, 117, 118, 85, 89, 90, 119, 87, 31, 110, 178, 73, 194, 39, 56, 139, 61; (2) System Code: 722225; UDI: 00884838099265; System Serial Number: 104, 153, 46, 28, 72, 208, 41, 122, 147, 376, 262, 331, 112, 110, 207, 375, 404, 405, 68, 177, 291, 299, 400, 29, 141, 216, 217, 71, 37, 175, 205, 228, 229, 157, 340, 453, 53, 259, 260, 300, 268, 55, 235, 298, 233, 354, 289, 148, 249, 434, 435, 409, 84, 111, 227, 455, 365, 284, 362, 468, 56, 232, 230, 269, 345, 296, 462, 374, 246, 324, 128, 241, 180, 367, 431, 287, 450, 460, 152, 292, 145, 124, 475, 306, 469, 470, 437, 248, 33

UPC codes

00884838085350, 00884838099265, 00884838116788

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.